About the study

A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

for mUC Cohort:

1. Histologically documented, locally advanced or metastatic UC (also termed TCC or urothelial cell carcinoma of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
2. Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing
3. Disease progression during or following treatment with no more than one platinum-containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence
4. ECOG Performance Status of 0 or 1
5. Measurable disease (at least one target lesion) according to RECIST v1.1
6. Adequate hematologic and end-organ function
7. Negative HIV test at screening
8. Negative total hepatitis B core antibody (HBcAb) test and hepatitis C virus (HCV) antibody at screening
9. Tumor accessible for biopsy
10. For women of childbearing potential: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating eggs
11. For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.